AI
Tuesday, March 14, 2017 1:49:32 PM
BB - if the rules for onsets have not changed and if the 100% onset is still tracking to occur in 2017, the only way that it is remotely possible for the 80% onset to occur in June is if Amarin gets event updates once every 5 months or so and barely and missed their target number by the previous update.
Keep in mind that the event rate doesn't change much through out the trial, as evidenced by the steady 4.8-5.0 composite rate. After reaching full enrollment, we average approximately 30 events per month.
So for your example to be possible, numbers would have to be something like this (adding 150 events every 5 months):
March 2016: 980 (for HD: adjudicated events + those being adjudicated and will be events
)
August 2016: 1130
January 2017: 1280
June 2017: 1430 (onset of 80%)
But the reason why this is highly unlikely is because (let's work backward): Thero said that 100% onset will occur in EOY 2017 AND is approximately 6 months after the 80% decision (3Q), therefore the 80% is most likely tracking to occur in early July. Then how could the 80% onset possibly occur 1 month before that? We know that they need at least 3 months for the IA process. So I see no possible way for the 80% onset to occur after early April.
Keep in mind that the event rate doesn't change much through out the trial, as evidenced by the steady 4.8-5.0 composite rate. After reaching full enrollment, we average approximately 30 events per month.
So for your example to be possible, numbers would have to be something like this (adding 150 events every 5 months):
March 2016: 980 (for HD: adjudicated events + those being adjudicated and will be events
) August 2016: 1130
January 2017: 1280
June 2017: 1430 (onset of 80%)
But the reason why this is highly unlikely is because (let's work backward): Thero said that 100% onset will occur in EOY 2017 AND is approximately 6 months after the 80% decision (3Q), therefore the 80% is most likely tracking to occur in early July. Then how could the 80% onset possibly occur 1 month before that? We know that they need at least 3 months for the IA process. So I see no possible way for the 80% onset to occur after early April.
